China: A Huge Medical Device Market with Prospects and Challenges
China’s medical device market has grown significantly over the last five years, but with that growth comes some pitfalls.
Tag Archives: insurance
The Transformation to True Digital Healthcare
Digital health tools and technology have the potential to dramatically improve the patient care experience, but the shift requires purposeful coordination and planned architecture.
Asian Governments, Private Sector Response to Pandemic Shows Opportunity, Challenge
In general, the Asian markets have controlled the COVID-19 virus successfully outside of China, but its effect has still led to new developments and trends.
Tech Q&A: Artificial Intelligence Has Promise of Streamlining Hospital Processes, Diagnostic Tools
Companies developing technologies that integrate AI need to consider regulatory concerns, community demographics, fitting into existing workflows, technical proficiency of both the hospital personnel and consumers.
In Many Asian Markets, Pandemic Making Telemedicine the New Normal
COVID-19 is driving patients to seek telehealth solutions, and it won’t be a short-term boom.
Protecting IP Should Remain a Critical Part of Medtech Business Strategy
A look at IP litigation in 2019 and the year ahead, and some advice on how medical device companies can safeguard their intellectual property.
Humanitarian Use Devices and Third-Party Reimbursement
Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?
Payers often apply the same evidence standards to Humanitarian Use Devices as other devices and demand high quality clinical trials, following an approach similar to the PMA or 510(k) regulatory pathways, where payers frequently impose a higher evidence standard than FDA. But how flexible are payers in setting their evidence requirements? Will they consider HUDs as investigational?
